Recall Z-0917-2026— Datascope Corp.

Name: FDA recall Z-0917-2026
Creator: U.S. Food and Drug Administration
Published: 2025-11-04

Class II · Ongoing

Class II FDA medical device recall by Datascope Corp., initiated 2025-11-04. It names one FDA 510(k) clearance: K163542. Product: Cardiosave Rescue. Intra-Aortic Balloon Pump system.. Reason: The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023..

Recalling firm: Datascope Corp.
Classification: Class II
Status: Ongoing
Initiated: 2025-11-04
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K163542 — CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage CaseDatascope Corp.·cleared 2017-01-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Cardiosave Rescue. Intra-Aortic Balloon Pump system.

Reason for recall

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

Data sourced from openFDA. This site is unofficial and independent of the FDA.